Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy

NCT ID: NCT06924606

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-06-26

Brief Summary

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This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.

Detailed Description

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Conditions

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Advanced NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.

Group Type EXPERIMENTAL

JS207 injection +docetaxel

Intervention Type DRUG

Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.

Arm B

Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.

Group Type EXPERIMENTAL

JS207 injection +JS004 injection

Intervention Type DRUG

Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.

Arm C

Patients receive JS207 10mg/kg or other dosage .

Group Type EXPERIMENTAL

JS207 injection

Intervention Type DRUG

Patients receive JS207 10mg/kg or other dosage.

Interventions

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JS207 injection +docetaxel

Patients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.

Intervention Type DRUG

JS207 injection +JS004 injection

Patients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.

Intervention Type DRUG

JS207 injection

Patients receive JS207 10mg/kg or other dosage.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
2. Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1/PD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1/PD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).
3. Subjects must have at least one measurable lesion according to RECIST v1.1.

Exclusion Criteria

1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
2. Sensitivity mutation of EGFR or ALK fusion.
3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Jilin Cancer Hospital

Jilin, Changchun, China

Site Status RECRUITING

Hunan Cancer Hospital

Hunan, Changsha, China

Site Status RECRUITING

West China Hospital, Sichuan University

Sichuan, Chengdu, China

Site Status RECRUITING

Second Affiliated Hospital, PLA Academy of Military Medical Sciences

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Army Medical Center, PLA

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China

Site Status RECRUITING

Anyang Tumor Hospital

Anyang, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status RECRUITING

The First People's Hospital of Changde

Changde, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Jiangxi, Nanchang, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The Third People's Hospital of Datong

Datong, Shanxi, China

Site Status RECRUITING

Yibin Second People's Hospital

Yibin, Sichuan, China

Site Status RECRUITING

Affiliated Tumor Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xiaojun Wang, Master

Role: CONTACT

Phone: 021-50796193

Email: [email protected]

Facility Contacts

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Tongmei Zhang, Doctor

Role: primary

Ying Liu, Doctor

Role: primary

Lin Wu, Doctor

Role: primary

Panwen Tian, Doctor

Role: primary

Bo Zhu, Doctor

Role: primary

Mengxia Li, Doctor

Role: primary

Chengzhi Zhou, Doctor

Role: primary

Yan Yu, Doctor

Role: primary

Yuanyuan Ji, Doctor

Role: primary

Zhiye Zhang, Doctor

Role: primary

Yinghua Ji, Doctor

Role: primary

Zhijun Wu, Doctor

Role: primary

Longhua Sun, Doctor

Role: primary

Peng Zhang, Doctor

Role: primary

Chengxu Cui, Doctor

Role: primary

Xujuan Ye, Doctor

Role: primary

Zhigang Han, Doctor

Role: primary

Chunxia Su, Doctor

Role: primary

Other Identifiers

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JS207-004-II-NSCLC

Identifier Type: -

Identifier Source: org_study_id